Abstract
Although routine health care and clinical trials usually require the documentation of similar information, data collection is performed independently from each other, resulting in redundant documentation efforts. Standardizing routine documentation can enable secondary use for medical research. Neuroinflammatory demyelinating diseases (NIDs) represent a heterogeneous group of diseases requiring further research to improve patient management. The aim of this work is to develop, implement and evaluate a minimal core dataset in routine health care with a focus on secondary use as case study for NIDs. Therefore, a draft minimal core dataset for NIDs was created by analyzing routine, clinical trial, registry, biobank documentation and existing data standards for NIDs. Data elements (DEs) were converted into the standard format Operational Data Model, semantically annotated and analyzed via frequency analysis. The analysis produced 1958 DEs based on 864 distinct medical concepts. After review and finalization by an interdisciplinary team of neurologists, epidemiologists and medical computer scientists, the minimal core dataset (NID CDEs) consists of 46 common DEs capturing disease-specific information for reuse in the discharge letter and other research settings. It covers the areas of diagnosis, laboratory results, disease progress, expanded disability status scale, therapy and magnetic resonance imaging findings. NID CDEs was implemented in two German university hospitals and a usability study in clinical routine was conducted (participants n = 16) showing a good usability (Mean SUS = 75). From May 2017 to February 2018, 755 patients were documented with the NID CDEs, which indicates the feasibility of developing a minimal core dataset for structured documentation based on previously used documentation standards and integrating the dataset into clinical routine. By sharing, translating and reusing the minimal dataset, a transnational harmonized documentation of patients with NIDs might be realized, supporting interoperability in medical research.
Highlights
Documentation in routine health care is very heterogeneous and unstructured [1]
From May 2017 to February 2018, 755 patients were documented with the neuroinflammatory demyelinating disease (NID) common data element (CDE), which indicates the feasibility of developing a minimal core dataset for structured documentation based on previously used documentation standards and integrating the dataset into clinical routine
The Unified Medical Language System (UMLS) codes for medical concepts were assigned according to the coding principles published by Varghese and Dugas [49]
Summary
Documentation in routine health care is very heterogeneous and unstructured [1]. Given a certain disease, the captured documentation of two different hospitals will usually differ significantly [2]. In clinical routine care, across clinical trials or pragmatic trials [3] a low degree of standardization in data collection limits the validity of possible clinically relevant results [4]. A trade-off must be found between extensive data collection as practiced in trials, and the capacity of physicians to document all elements during routine care on top of their daily documentation load. This problem has been addressed by multiple institutions, including the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Health (NIH) and the Clinical Data Interchange Standards Consortium (CDISC) [6,7,8]. By developing so-called common data elements (CDEs) for various disease entities, such as spinal cord injuries and epilepsy, or the Clinical Data Acquisition Standards Harmonization (CDASH), basic standards for the collection of clinical trial data have been published [9,10,11]
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